Freelite Human Lambda Free Kit Recalled for Calibration Curve Error
The Binding Site Group is recalling Freelite Human Lambda Free Kits due to a calibration curve change that causes an increase in false prozone flags.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for monitoring serious diseases where a defect (false prozone flags) poses a risk of harm through inaccurate results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
The Binding Site Group, Ltd. is recalling 3,088 units of the Freelite Human Lambda Free Kit for use on SPAPLUS. The affected product codes are LK018.S and LK018.10S, and the specific lots involved are #400012 and #400257. This kit is used to aid in the detection and monitoring of Multiple Myeloma and related diseases.
The recall was initiated because a change in the calibration curve is causing an increase in false prozone flags. This technical issue may affect the accuracy of the test results.
The affected products were distributed nationwide in the United States and internationally to Canada and Australia. Healthcare providers and laboratories should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 3,088
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #400012
- 400257
Distribution
Distributed nationwide across the United States.
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